Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The Biotech Times Editorial Team  · 
Biotech

SGU and Taaleem open medical school pathways for UAE students

St. George's University and UAE school group Taaleem have signed an MoU giving eligible students access to MD admissions pathways and up to USD
St. George's University and UAE school group Taaleem have signed an MoU giving eligible students access to MD admissions pathways and up to USD
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

AirNexis AN01 meets primary endpoint in Phase 2b COPD study

Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
Dual PDE3/4 inhibitor AN01 improved lung function versus placebo in COPD patients already on bronchodilator therapy, with data presented at ERS 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

Apnimed files NDA for OSA drug Oxnimbi ahead of $221m Nasdaq IPO

The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a
The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Assembly Bio exercises Gilead profit-share option for HSV drug programme

Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
Assembly Biosciences will take a 40% share of US costs and profits for the GS-1179 helicase-primase inhibitor as a Phase 2 trial approaches.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

BBOT reports 75% ORR for BBO-8520 plus pembrolizumab in 2L+ NSCLC

BridgeBio Oncology Therapeutics posted new Phase 1 data showing its KRAS G12C inhibitor combo achieved a 75% response rate in inhibitor-experienced lung cancer patients.
BridgeBio Oncology Therapeutics posted new Phase 1 data showing its KRAS G12C inhibitor combo achieved a 75% response rate in inhibitor-experienced lung cancer patients.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

BrainChild Bio closes $116m Series A to fund pivotal DIPG CAR-T trial

The Seattle-based biotech will use proceeds to run its ILLUMINATE Phase 2 study of BCB-276 in diffuse intrinsic pontine glioma, a universally fatal
The Seattle-based biotech will use proceeds to run its ILLUMINATE Phase 2 study of BCB-276 in diffuse intrinsic pontine glioma, a universally fatal
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics

Dyne Therapeutics to share one-year ACHIEVE DM1 data at WMS and AANEM

Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
Dyne will present pooled Phase 1/2 data for z-basivarsen against a matched natural history cohort, with registrational topline results due Q1 2027.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Vor Bio completes UPSTREAM MG enrolment and launches oMG trial

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Korsana Biosciences lists on Nasdaq after $380m raise

The Waltham-based neurodegenerative disease biotech completed its merger with Cyclerion and a $380m private placement, beginning Nasdaq trading under "KRSA" on 9
The Waltham-based neurodegenerative disease biotech completed its merger with Cyclerion and a $380m private placement, beginning Nasdaq trading under "KRSA" on 9
The Biotech Times Editorial Team  · 
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